Federal Register / Vol. 63, No. 132 / Friday, July 10, 1998 / Proposed Rules 37307

this section, the ‘‘medical benefits

package’’ does not include the

following:

(1) Abortions and abortion

counseling.

(2) Drugs, biologicals, and medical

devices not approved by the Food and

Drug Administration unless the treating

medical facility is conducting formal

clinical trials under an Investigational

Device Exemption (IDE) or an

Investigational New Drug (IND)

application, or the drugs, biologicals, or

medical devices are prescribed under a

compassionate use exemption.

(3) Gender alterations.

(4) Hospital and outpatient care for a

veteran who is either a patient or inmate

in an institution of another government

agency if that agency has a duty to give

the care or services.

(5) Infertility services.

(6) Membership in spas and health

clubs.

(7) Pregnancy and delivery.

(8) Reproductive sterilization, unless

medically necessary.

(9) Surgery to reverse voluntary

sterilization.

(10) Surgical implantation of penile

prostheses.

(Authority: 38 U.S.C. 101, 501, 1701, 1705,

1710, 1721, 1722)

§ 17.43 [Amended]

5–6. In § 17.43, paragraph (a) is

removed and paragraphs (b) through (e)

are redesignated as paragraphs (a)

through (d), respectively.

§ 17.47 [Amended]

7. In § 17.47, paragraph (h) is

removed; paragraphs (i) through (l) are

redesignated as paragraphs (h) through

(k), respectively; and newly

redesignated paragraph (h) is amended

by removing ‘‘hospital or’’ and by

removing ‘‘or hospital care in a Federal

hospital under agreement,’’.

§ 17.93 [Amended]

8. In § 17.93, paragraph (a)(2) is

amended by removing ‘‘Medical

services’’ and adding, in its place,

‘‘Subject to the provisions of §§ 17.36

through 17.38, medical services’’.

§ 17.99 [Removed]

9. Section 17.99 is removed.

§ 17.100 [Amended]

10. In § 17.100, the third sentence is

amended by removing ‘‘a new

application is filed, and’’.

[FR Doc. 98–18302 Filed 7–9–98; 8:45 am]

BILLING CODE 8320–01–P

ENVIRONMENTAL PROTECTION

AGENCY

40 CFR Part 52

[OH 114–1b; FRL–6123–2]

Approval and Promulgation of

Maintenance Plan Revision; Ohio

AGENCY: Environmental Protection

Agency.

ACTION: Proposed rule.

SUMMARY: The United States

Environmental Protection Agency (EPA)

is proposing to approve a March 13,

1998, request from Ohio, for a State

Implementation Plan maintenance plan

revision for the Columbus ozone

maintenance area. The maintenance

plan revision establishes an out year of

2010 for the area’s emissions budget.

The maintenance plan revision also

allocates to the 2010 mobile source

emissions budget a portion of the area’s

safety margin. The 2010 mobile source

emissions budget will be used for

transportation conformity purposes. The

safety margin is the difference between

the attainment inventory level of the

total emissions and the projected levels

of the total emissions in the final year

of the maintenance plan.

In the final rules section of this

Federal Register, EPA is approving the

State’s requests as a direct final rule

without prior proposal because EPA

views this action as noncontroversial

and anticipates no adverse comments. A

detailed rationale for approving the

State’s request is set forth in the direct

final rule. The direct final rule will

become effective without further notice

unless the Agency receives relevant

adverse written comment on the rule.

Should the Agency receive such

comment, it will publish a notice

informing the public that the direct final

rule did not take effect and such public

comment received will be addressed in

a subsequent final rule based on this

proposed rule. If no adverse written

comments are received, the direct final

rule will take effect on the date stated

in that document and no further activity

will be taken on this proposed rule. EPA

does not plan to institute a second

comment period on this action. Any

parties interested in commenting on this

action should do so at this time.

DATES: Written comments on this

proposed action must be received by

August 10, 1998.

ADDRESSES: Written comments should

be sent to: J. Elmer Bortzer, Chief,

Regulation Development Section, Air

Programs Branch, (AR–18J), U.S.

Environmental Protection Agency,

Region 5, 77 West Jackson Boulevard,

Chicago, Illinois, 60604.

FOR FURTHER INFORMATION CONTACT:

Scott Hamilton, Environmental

Scientist, Regulation Development

Section, Air Programs Branch (AR–18J),

U.S. Environmental Protection Agency,

Region 5, 77 West Jackson Boulevard,

Chicago, Illinois 60604, (312) 353–4775.

SUPPLEMENTARY INFORMATION: For

additional information, see the Direct

Final document which is located in the

Rules section of this Federal Register.

Copies of the requests are available for

inspection at the following address:

(Please contact Scott Hamilton at (312)

353–4775 before visiting the Region 5

office.) USEPA Region 5, Air and

Radiation Division, 77 West Jackson

Boulevard, Chicago, Illinois 60604–

3590.

List of Subjects in 40 CFR Part 52

Environmental protection, Air

pollution control, Hydrocarbons,

Intergovernmental relations, Ozone,

Nitrogen oxides, Transportation

conformity.

Authority: 42 U.S.C. 7401 et seq.

Dated: July 1, 1998.

David A. Ullrich,

Acting Regional Administrator.

[FR Doc. 98–18421 Filed 7–9–98; 8:45 am]

BILLING CODE 6560–50–P

ENVIRONMENTAL PROTECTION

AGENCY

[OPP–300680; FRL–6016–1]

40 CFR Part 180

RIN 2070–AB18

Food and Food By-Products Used as a

Pesticide; Proposed Exemption From

the Requirement of a Tolerance

AGENCY: Environmental Protection

Agency (EPA).

ACTION: Proposed rule.

SUMMARY: EPA proposes to establish an

exemption from the requirement of a

tolerance for residues of any edible food

commodity (except for peanuts, tree

nuts, milk, soybean, eggs, fish,

crustacea, and wheat) used as a

pesticide, when applied in accordance

with good agricultural practices, in or

on all food commodities. Any edible

food commodity used as a pesticide

under this exemption must not be

‘‘adulterated food’’ as defined in FFDCA

section 402. 21 U.S.C. 342. The

exemption from the requirement of a

tolerance is being proposed by the

Agency on its own initiative, since the
37308 Federal Register / Vol. 63, No. 132 / Friday, July 10, 1998 / Proposed Rules

Agency believes that the exemption for

edible food commodities will be safe.

DATES: Comments, identified by the

docket control number [OPP–300680],

must be received on or before

September 8, 1998.

ADDRESSES: By mail, submit written

comments to: Public Information and

Records Integrity Branch, Information

Resources and Services Division

(7502C), Office of Pesticide Programs,

Environmental Protection Agency, 401

M St., SW., Washington, DC 20460. In

person, deliver comments to: Rm. 119,

CM #2, 1921 Jefferson Davis Highway,

Arlington, VA 22202. Information

submitted as a comment concerning this

document may be claimed confidential

by marking any part or all of that

information as ‘‘Confidential Business

Information’’ (CBI). Information so

marked will not be disclosed except in

accordance with procedures set forth in

40 CFR part 2. A copy of the comment

that does not contain CBI must be

submitted for inclusion in the public

record. Information not marked

confidential will be included in the

public docket by EPA without prior

notice. The public docket is available

for public inspection in Rm. 119 at the

address given above, from 8:30 a.m. to

4 p.m., Monday through Friday,

excluding legal holidays.

Comments and data may also be

submitted electronically by following

the instructions under Unit IV of this

document. No Confidential Business

Information (CBI) should be submitted

through e-mail.

FOR FURTHER INFORMATION CONTACT: By

mail: Freshteh Toghrol, Biopesticides

and Pollution Prevention Division

(7511W), Office of Pesticide Programs,

Environmental Protection Agency, 401

M St. SW., Washington, DC 20460.

Office location, telephone number, and

e-mail address: Crystal Station #1, 5th

Floor, 2805 Crystal Drive, Arlington, VA

22202; (703) 308–7014;

toghrol.freshteh@epamail.epa.gov.

SUPPLEMENTARY INFORMATION: Pursuant

to section 408(e) of the Federal Food,

Drug and Cosmetic Act (FFDCA), 21

U.S.C. 346a(e), EPA proposes to amend

40 CFR part 180 by establishing an

exemption from the requirement of a

tolerance for residues of any edible food

commodity (except for peanuts, tree

nuts, milk, eggs, fish, crustacea, and

wheat) used as a pesticide, when

applied in accordance with good

agricultural practices in or on all food

commodities. By edible food

commodity, EPA means foods that are

widely consumed for their nutrient

properties. This exemption would not

apply to any ‘‘adulterated food’’ under

FFDCA section 402.

I. Statutory Authority

New section 408(c)(2)(A)(i) allows

EPA to establish an exemption from the

requirement of a tolerance (the legal

limit for a pesticide chemical residue in

or on a food) only if EPA determines

that the exemption from tolerance is

‘‘safe.’’ Section 408(c)(2)(A)(ii) defines

‘‘safe’’ to mean that‘‘ there is a

reasonable certainty that no harm will

result from aggregate exposure to the

pesticide chemical residue, including

all anticipated dietary exposures and all

other exposures for which there is

reliable information.’’ This includes

exposure through drinking water and in

residential settings, but does not include

occupational exposure. Section

408(c)(2)(B) requires EPA to give special

consideration to exposure of infants and

children to the pesticide chemical

residue in establishing an exemption

and to ‘‘ensure that there is a reasonable

certainty that no harm will result to

infants and children from aggregate

exposure to the pesticide chemical

residue....’’ EPA performs a number of

analyses to determine the risks from

aggregate exposure to pesticide residues.

First, EPA determines the toxicity of

pesticides. Second, EPA examines

exposure to the pesticide through food,

drinking water, and through other

exposures that occur as a result of

pesticide use in residential settings.

II. Risk Assessment and Statutory

Findings

Under the conditions of the proposed

tolerance exemption for residues of any

edible food commodity used as a

pesticide (as defined above) in or on all

food commodities, and in consideration

of the conditions, criteria, and

requirements set forth by FQPA, the

Agency believes that this tolerance

exemption will be safe for humans,

including infants and children. This

exemption only applies to those foods

that have been widely consumed for

their nutrient properties. Any safety

concerns regarding exposure to residues

of such edible food commodities have

been addressed by the long history of

safe use of these foods in commerce, as

well as the adequate regulation of foods

by the Food and Drug Administration.

Additionally, any cumulative effects

from aggregate exposure to residues of

food commodities when used as

pesticides in or on other food

commodities would not likely impact

those effects that may occur from much

broader exposure via consumption of

food in the diet.

Some edible foods produce an allergic

reaction in certain individuals. Allergy

to food proteins occurs in less than 1 to

2% of the population. The majority of

individuals with documented

immunologic reactions to foods exhibit

immunoglobulin E (IgE)-mediated

immediate hypersensitivity reactions

that can be sudden and severe. Current

scientific knowledge suggest that

common food allergens are glycosylated

proteins, which tends to be resistant to

degradation by heat, acid, and proteases.

Where food allergy is confirmed

patients are usually allergic to only a

few specific proteins within one or two

specific foods. Eight food or food groups

(peanut, soybean, tree nuts, milk, eggs,

fish, crustacea, and wheat) account for

the vast majority of documented food

allergies worldwide (the Food and

Agriculture Organization (FAO) of the

United Nation: Report of the FAO

Technical Consultation on Food

Allergies, Rome, Italy, November 13-14,

1995). Even though, as explained below,

there are unlikely to be significant

residues from use of edible food as a

pesticide, the Agency has decided not to

include those known allergenic food

commodities in this exemption.

The Agency believes that food

commodities will be used as pesticides

to control or mitigate pests or as plant

growth regulators in only very limited

cases. It is unlikely that an edible food

commodity could be used to control a

pest via a toxic mode of action. This

assumption is supported by the

Agency’s experience to date where food

commodities have been used to attract,

repel or otherwise suppress pests. The

purported mechanisms of action for

food commodities involve feeding

deterrence for herbivorous insects or

mammals or an alteration in the

microbial flora which suppresses the

microbial pests. In the case of an altered

microbial populations, it is necessary

for the food commodity to be degraded

or metabolized before the desired effect

can occur.

The Agency also believes that

residues from any edible food

commodity, when used as a pesticide on

another food commodity would be

minimal to non-existent because of

rapid degradation in the environment.

No tolerances or exemptions from

requirements of tolerances have been

issued in the United States or

internationally for all food commodities

as biochemical pesticides; however,

some individual foods or food byproducts have tolerance exemptions in

the United States.

III. Safety Determination for U.S.

Population and Infants and Children

The Agency believes that this

tolerance exemption will be safe for

humans, including infants and children.
Federal Register / Vol. 63, No. 132 / Friday, July 10, 1998 / Proposed Rules 37309

Any safety concerns regarding exposure

to residues of edible food commodities

have been addressed by the long history

of safe use of foods in commerce, as

well as the adequate regulation of foods

by the Food and Drug Administration.

Additionally, any cumulative effects

from aggregate exposure to residues of

food commodities when used as

pesticides in or on other food

commodities would not likely impact

those effects that may occur from much

broader exposure via consumption of

food in the diet. Since food

commodities are non toxic to humans

including infants and children, EPA has

not assessed the risk from food

commodities using a safety factor

approach. Accordingly, application of

an additional 10X safety factor analysis

or quantitative risk assessment for the

protection of infants and children is not

necessary to protect the safety of infants

and children.

Consistent with section 408(b)(2)(D),

EPA has reviewed the available

scientific data and other relevant

information in support of this action.

Based on the information and data

considered, the Agency has determined

that, in amending 40 CFR 180.1164, as

proposed, there is reasonable certainty

that no harm to the general population,

including infants and children will

result from aggregate exposure to edible

food commodities used as pesticides.

An exemption from tolerance is

appropriate for these pesticides because

EPA believes they do not pose a dietary

risk under reasonably forseeable

circumstances. Accordingly, EPA

proposes that the exemption from the

requirement of a tolerance be

established as set forth below.

IV. Public Docket and Electronic

Submissions

The official record for this rule

making, as well as the public version,

has been established for this rule

making under document control number

[OPP–300680] (including comments and

data submitted electronically). A public

version of this record, including

printed, paper versions of electronic

comments, which does not include any

information claimed as CBI, is available

for inspection from 8:30 a.m. to 4

p.m.,Monday through Friday, excluding

legal holidays. The public record is

located in Room 119 of the Public

Information and Records Integrity

Branch, Information Resources and

Services Division (7502C), Office of

Pesticide Programs, Environmental

Protection Agency, Crystal Mall #2,

1921 Jefferson Davis Highway,

Arlington, VA. 22202.

Electronic comments may be sent

directly to EPA at:

opp-docket@epamail.epa.gov

Electronic comments must be

submitted as an ASCII file avoiding the

use of special characters and any form

of encryption.

The official record for this rule

making, as well as the public version, as

described above will be kept in paper

form. Accordingly, EPA will transfer

any copies of comments received

electronically into printed paper form as

they are received and will place the

paper copies in the official rule making

record. The official rule making record

is the paper record maintained at the

Virginia address in ‘‘ADDRESSES’’ at

the beginning of this document.

V. Regulatory Assessment

Requirements

This rule proposes an exemption from

the requirement of a tolerance under

FFDCA section 408(d). The EPA is

proposing this regulation on its own

initiative. The Office of Management

and Budget (OMB) has exempted these

types of actions from review under

Executive Order 12866, entitled

Regulatory Planning and Review (58 FR

51735, October 4, 1993). This action

does not contain any information

collections subject to OMB approval

under the Paperwork Reduction Act

(PRA), 44 U.S.C. 3501 et seq., or impose

any enforceable duty or contain any

unfunded mandate as described under

Title II of the Unfunded Mandates

Reform Act of 1995 (UMRA; Pub. L.

104–4). Nor does it require any prior

consultation as specified by Executive

Order 12875, entitled Enhancing the

Intergovernmental Partnership (58 FR

58093, October, 1993), or special

considerations as required by Executive

Order 12898, entitled Federal Actions to

Address Environmental Justice in

Minority Populations and Low-Income

Populations (59 FR 7629), February 16,

1994), or require OMB review in

accordance with Executive Order 13045,

entitled Protection of Children from

Environmental Health Risks and Safety

Risks (62 FR 19885, April 23, 1997).

Pursuant to the requirements of the

Regulatory Flexibility Act (Pub. L. 96–

354, 94 Stat. 1164, 5 U.S.C. 601–612),

the Agency previously assessed whether

establishing tolerances, exemptions

from tolerances, raising tolerance levels

or expanding exemptions might

adversely impact small entities and

concluded, as a generic matter, that

there is no adverse economic impact.

The factual basis for the Agency’s

generic certification for tolerance

actions published on May 4, 1981 (46

FR 24950), and was provided to the

Chief Counsel for Advocacy of the Small

Business Administration.

List of Subjects in 40 CFR Part 180

Environmental protection,

Agricultural commodities, Food

additives, Feed additives, Pesticides and

pests, Reporting and record keeping

requirements.

Dated: June 29, 1998.

Kathleen D. Knox,

Acting Director, Biopesticides and Pollution

Prevention Division, Office of Pesticide

Programs.

Therefore, 40 CFR chapter I, part 180

is proposed to be amended as follows:

PART 180—[AMENDED]

1. The authority citation for part 180

continues to read as follows:

Authority: 21 U.S.C. 346a and 371

2. Section 180.1164 is amended by

adding paragraph (d) to read as follows:

§ 180.1164 Food and food by-products;

exemption from the requirement of a

tolerance.

* * * * *

(d) Any edible food commodity

(except for peanuts, tree nuts, milk,

eggs, fish, crustacea, and wheat) used as

a pesticide is exempted from the

requirement of a tolerance when used in

accordance with good agricultural

practice in or on all food commodities.

This exemption shall not apply to any

edible food commodity that is

adulterated under section 342 of Title

21 of the United States Code.

[FR Doc. 98–18280 Filed 7–9–98; 8:45 am]

BILLING CODE 6560–50–F

ENVIRONMENTAL PROTECTION

AGENCY

40 CFR Parts 264 and 265

[IL–64–2–5807; FRL–6122–8]

Project XL Site-specific Rulemaking for

OSi Specialties, Inc., Sistersville, WV

AGENCY: Environmental Protection

Agency (EPA).

ACTION: Supplemental proposal.

SUMMARY: This document proposes a

narrow modification being considered

by the EPA in implementing a project

under the Project XL program for the

OSi Specialties, Inc., plant, a wholly

owned subsidiary of Witco Corporation,

located near Sistersville, West Virginia

(‘‘the Sistersville Plant’’). To implement

this XL project, the EPA proposed on

March 6, 1998, a site-specific regulatory

deferral of certain air emission

standards. That action has not yet been